Biogen Idec Canada Inc., in consultation with Health Canada, would like to inform you that new safety information regarding the risk of PML is being added to the TECFIDERA Canadian Product Monograph. The update was prompted by a fatal case of PML reported in a clinical trial patient receiving TECFIDERA.

TECFIDERA is approved for the treatment of relapsing remitting multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the progression of disability.

A fatal case of PML was reported in a patient with severe and prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years). The patient had no other medical conditions that could have compromised immune system functions and had not been taking any other immunosuppressive or immunomodulatory medications concomitantly.

The Product Monograph for TECFIDERA is being updated to include the risk of PML. Given that a contributory role of TECFIDERA-induced lymphopenia in the development of PML cannot be excluded, the Product Monograph update will also recommend close lymphocyte monitoring.

Complete blood counts, including lymphocyte counts, should be obtained prior to treatment with TECFIDERA, then every 6 to 12 months and as clinically indicated. Interruption of TECFIDERA should be considered in patients with lymphocyte counts <0.5 X 109/L persisting for more than 6 months. After the interruption of TECFIDERA, lymphocyte counts should be followed until recovery.

The fatal case of PML was reported in October 2014. The patient was participating in the open-label ENDORSE study and received 4.5 years of TECFIDERA therapy. During treatment with TECFIDERA, the patient experienced severe and prolonged lymphopenia (over 3.5 years in duration), which is associated with an increased risk of PML.

PML is an opportunistic viral infection of the brain caused by the John Cunningham (JC) virus that occurs typically in patients who are immunocompromised and can lead to severe disability or death. Some symptoms of PML are similar to those of MS and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. At the first sign or symptom suggestive of PML, withhold TECFIDERA and perform an appropriate diagnostic evaluation.

Through surveillance, the manufacturer identified a risk associated with the product and has submitted to Health Canada an update to its product label to reflect the findings. The label changes have been reviewed and approved by Health Canada. A comprehensive internal signal assessment was not required for this issue, and therefore a Summary Safety Review is not available.